Abstract: The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.

Abstract: Screening assays and methods of performing such assays are provided. In certain examples, the assays and methods may be designed to determine whether or not two or more species can associate with each other. In some examples, the assays and methods may be used to determine if a known antigen binds to an unknown monoclonal antibody.

Abstract: A method for the treatment of cancer is provided wherein a cancer recognition (CARE) antigen or CARE antibody is administered to a patient. Administration of the CARE antigen or antibody will induce an immune or promote a response of IgM CARE antibodies which will bind to CARE antigen bound to cancer cells, inducing an immune response to destroy the cancer cells. Subsequent to said treatment, ELISA assays may be used to detect levels of said CARE antigen to monitor the efficacy of the treatment, and to govern the further administration of CARE antigens.

Abstract: Disclosed are compositions and methods for the labeling of two or more targets with different labels. Specifically, disclosed are compositions for biotin and the protection of biotin within multilabel assays which employ the biotin-biotin binding protein binding relationship for each distinct label in relation to targets such as nucleic acids, polypeptides, antibodies or cells. These multilabel assays are enabled through the use of biotin with desthiobiotin, orthogonal protecting schemes for biotin, or a combination of the approaches.

Abstract: Screening assays and methods of performing such assays are provided. In certain examples, the assays and methods may be designed to determine whether or not two or more species can associate with each other. In some examples, the assays and methods may be used to determine if a known antigen binds to an unknown monoclonal antibody.

Abstract: The present invention relates to a method for diagnosing Alzheimer's Disease (AD) using PKC-elicited gene expression profiles. PKC-activation elicits different genomic profiles in AD cells, as compared with control cells, which can be used to diagnose AD and individuals at risk for developing AD.

Abstract: The invention describes antibodies having a high affinity for aggregated forms of ?-synuclein and a low affinity for monomeric forms of ?-synuclein. The antibodies are useful in the diagnosis of neurodegenerative diseases.

Abstract: The present invention provides serum paraoxonase 1 protein as a biomarker useful for early diagnosis of lung cancer.

Abstract: The invention relates to a method of detecting a disease state or disease susceptibility in a mammalian subject which comprises detecting an antibody in a test sample comprising a bodily fluid from said mammalian subject wherein said antibody is a biological marker of a disease state or disease susceptibility, the method comprising: (a) contacting said test sample with a plurality of different amounts of an antigen specific for said antibody, (b) detecting the amount of specific binding between said antibody and said antigen, (c) plotting or calculating a curve of the amount of said specific binding versus the amount of antigen for each amount of antigen used in step (a) and (d) determining the presence or absence of said disease state or disease susceptibility based upon the amount of specific binding between said antibody and said antigen at each different antigen concentration used.

Abstract: Method, device and kit for the detection of antibodies directed to Feline Immunodeficiency Virus (FIV). The method includes contacting the felid biological sample with FIV env polypeptide and detecting whether the polypeptide substantially binds to the antibody in the biological sample. The method will detect FIV antibodies in a sample from animals that have been naturally infected but the method will not detect antibodies in a sample from animals that have not been infected and that have not been vaccinated with an FIV vaccine after within about the previous five to eight weeks.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises measuring assay signal resulting from background only and measuring assay signal resulting from the presence of analyte in the sample plus background and subtracting the first measurement from the second measurement to determine the concentration of analyte in the sample. For example, a measurement result 1 is determined by means of an assay conducted on a portion of the sample where analyte in the sample is substantially sequestered and a measurement result 2 is determined by means of the assay conducted on an equal portion of the same sample where analyte in the sample is substantially non-sequestered. Measurement result 1 is subtracted from measurement result 2 to determine the concentration of analyte in the sample.

Abstract: Methods, compositions and kits are disclosed directed at posaconazole fragments, immunogens, signal generating moieties, antibodies that bind posaconazole and immunoassays for detection of posaconazole.

Abstract: A method for manufacturing a biochip is provided. First, a first self-assembled monolayer is coated on a substrate. Next, a plurality of first biomedical molecular dots are formed on the first self-assembled monolayer by micro-titration technique. After the bonding reaction between the first biomedical molecular point and the first self-assembled monolayer, a second self-assembled monolayer is deposited on the surface of the first self-assembled monolayer by evaporation. The second self-assembled monolayer attached on the plurality of first biomedical molecular dots and the first self-assembled monolayer not bonded to the substrate are removed, so that the first biomedical molecular dots immobilized on the first self-assembled monolayer are exposed. Finally, a second biomedical molecular layer is immobilized on the exposed portions of the first biomedical molecular dots.

Abstract: The subject invention relates in part to the surprising and unexpected discovery that insects that are resistant to Bacillus thuringiensis Cry toxins have measurably altered alkaline phosphatase (ALP) activity as compared to insects that are susceptible to Cry toxins. This and other surprising discoveries reported herein have broad implications in areas such as managing and monitoring the development of insect resistance to B.t. toxins. For example, the subject invention provides a simple and fast assay (enzymatic or otherwise) for detecting ALP activity levels and thereby monitoring the development of resistance by insects to crystal protein insect toxins. There was no prior motivation or suggestion to go about resistance monitoring using this simple and easy approach.

Abstract: The invention provides a method for producing a multicellular spheroid comprising injecting a cell suspension into a gel. The invention also provides a method of producing a gel comprising one or more multicellular spheroids, the method comprising injecting a cell suspension into a gel, as well as a gel obtainable by the method. Also provided is a method of assessing the effect of an agent on the property of a cell selected from any of survival, growth, proliferation, differentiation, migration, morphology, signalling, metabolic activity, gene expression and cell-cell interaction, the method comprising (i) producing a multicellular spheroid or gel according to the method of the invention, or providing a gel according to the invention; and (ii) assessing the effect of the agent on the property of a cell in the multicellular spheroid.

Abstract: The disclosure provides, among other things, molecular markers for categorizing the neoplastic state of a patient, methods for using the molecular markers in diagnostic tests, nucleic acid and amino acid sequences related to the molecular markers, reagents for detection of molecular markers, and methods for identifying candidate molecular markers in highly parallel gene expression data.

Abstract: The invention provides methods for treatment of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: A method is disclosed for making a conjugate of two molecules using a hydrazide thiol linker. In a particular working embodiment, an Fc-specific antibody-enzyme conjugate is made using the method and demonstrated to provide exceptional staining sensitivity and specificity in immunohistochemical and in situ hybridization assays.

Abstract: The present disclosure provides methods and compositions for the production of chimeric antibodies that specifically bind an antigen of interest.

Abstract: An imaging method utilizing a split peroxidase is described herein. Imaging methods involve contacting a cell with a split peroxidase and a substrate thereof to allow conversion of a substrate into a product via an enzymatic reaction catalyzed by the reconstitute split peroxidase. Also disclosed herein are split peroxidases, related products and kits.

Abstract: This invention provides a digital microfluidic manipulation device and a manipulation method thereof. This device comprises a PDMS membrane having a surface comprising a plurality of hydrophobic microstructures; a plurality of air chambers arranged in an array and placed under the PDMS membrane; and a plurality of air channels, each of which connects to a corresponding one of the plurality of air chambers. When a suction force is transmitted via one of the plurality of air channels to the corresponding air chamber, a portion of the PDMS membrane above the air chamber deforms toward the air chamber, so that the surface morphology and the contact angle of the liquid/solid interface of the surface comprising the plurality of hydrophobic microstructures are altered and thereby to drive droplets.

Abstract: Disclosed is an analysis method comprising the steps of: (a) reacting a substance to be analyzed with at least a specific partner which exhibits a selective interaction with the substance, converting a soluble substance to an insoluble substance by an insolubilization reaction, in correlation with the amount of the substance to be analyzed contained in a sample, and depositing the insoluble substance on a sensing part, and (b) electrically analyzing the insoluble substance deposited on the sensing part, wherein at least one of steps (a) and (b) is carried out under flow conditions.

Abstract: Provided is a method of measuring the presence and/or the amount of glucagon-like peptide-1 (GLP-1) in a sample, which method is characterized by comprising the step of treating the sample in advance with an acidic solution, and a kit of measuring the presence and/or an amount of GLP-1 in a sample, the kit containing (a) the acidic solution, (b) an antibody specific to GLP-1, and (c) an instruction manual.

Abstract: A sample compressor applies pressure to a sample collector and a sample application zone of a test strip to transfer a sample from the sample collector and a binding partner of an analyte to the sample application zone in a lateral flow device. At least one of the binding partners of the analyte is not located on the test strip prior to use of the lateral flow device. The test strip may be a universal test strip with no molecule that specifically binds the analyte is located on the test strip. The sample compressor may be a universal sample compressor also with no molecule that specifically binds the analyte on the sample compressor. The lateral flow device may also include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone.

Abstract: A composition includes a first probe and a first initiator bonded to the first probe. The first probe is capable of binding to an analyte and the first initiator is capable of initiating a controlled polymerization reaction. An associated kit, device, and method are provided.

Abstract: A composition includes a first probe, a first initiator component bonded to the first probe, a second probe, and a second initiator component bonded to the second probe. The first probe and the second probe are capable of binding to a single analyte, and the first initiator component and the second initiator component are capable of forming an initiator when present in proximity to each other and when the first probe and the second probe are bonded to the analyte. An associated kit, device, and method are provided.

Abstract: The present disclosure relates to microfluidic devices adapted for facilitating cytometry analysis of particles flowing therethrough. In certain embodiments, the microfluidic devices have onboard sterilization capabilities. In other embodiments, microfluidic devices have integral collection bags and methods for keeping the microfluidic channels clean.

Abstract: Blood-brain barrier permeable peptide compositions that contain variable antigen binding domains from camelid and/or shark heavy-chain only single-domain antibodies are described. The variable antigen binding domains of the peptide compositions bind to therapeutic and diagnostic biomarkers in the central nervous system, such as the amyloid-beta peptide biomarker for Alzheimer's disease. The peptide compositions contain constant domains from human IgG, camelid IgG, and/or shark IgNAR. The peptide compositions include heavy-chain only single-domain antibodies and compositions with one or more variable antigen binding domain, bound to one or more constant domains.

Abstract: The present invention provides compositions and methods for detection and analysis of intracellular binding of a bioactive agent to a cellular target. In particular, provided herein are bioactive agents tethered to fluorophores, cellular targets fused to bioluminescent reporters, and methods of detecting and analyzing the interaction of bioactive agents with cellular targets therewith.

Abstract: The present invention provides compositions and methods for detection and analysis of intracellular binding of a bioactive agent to a cellular target. In particular, provided herein are bioactive agents tethered to fluorophores, cellular targets fused to bioluminescent reporters, or portions, components, or subunits of bioluminescent reporters, and methods of detecting and analyzing the interaction of bioactive agents with cellular targets therewith.

Abstract: Methods and reagents are disclosed for conducting assays for EDDP. The reagents include a moiety selected from the group consisting of poly(amino acid) label moieties, non-poly (amino acid) label moieties, poly(amino acid) immunogenic carriers, non-poly(amino acid) immunogenic carriers, non-label poly(amino acid) moieties, and non-immunogenic carrier poly(amino acid) moieties linked to 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine at the 3-position of one of the phenyl rings. Antibodies produced from immunogenic EDDP conjugates and labeled EDDP conjugates are employed in assays for determining the presence and/or amount of EDDP in samples suspected of containing EDDP.

Abstract: Screening assays and methods of performing such assays are provided. In certain examples, the assays and methods may be designed to determine whether or not two or more species can associate with each other. In some examples, the assays and methods may be used to determine if a known antigen binds to an unknown monoclonal antibody.

Abstract: Systems and methods for diagnosing acute kidney injury following an acute event or surgical intervention, based on assessing the biomarker L-FABP. Also, systems and methods for predicting the risk of an individual to suffer from a kidney injury after an acute event or surgical intervention in the future.

Abstract: The purpose of the present invention is to provide a method for detecting even mucin 1 derived from breast cancer, which cannot be detected by a CA15-3 measurement method. The purpose can be achieved by a method for analyzing the mucin 1 having a Sulfo-3Gal?1-3GalNAc-R carbohydrate chain, including: a step of bringing a 3? sulfonated core 1 carbohydrate chain binding probe capable of binding to the Sulfo-3Gal?1-3GalNAc-R carbohydrate chain into contact with a sample to be tested; a step of bringing a 3? sulfonated core 1 carbohydrate chain mucin 1 peptide binding probe capable of binding to the mucin 1 having a Sulfo-3Gal?1-3GalNAc-R carbohydrate chain or a mucin 1 binding probe capable of binding to a mucin 1 into contact with the sample to be tested; and a step of detecting a conjugate of the mucin 1 having a Sulfo-3Gal?1-3GalNAc-R carbohydrate chain and probe.

Abstract: The composition includes a first probe and a first initiator bonded to the first probe. The composition further includes a second probe and a second initiator bonded to the second probe. The first probe and the second probe are capable of binding to a single analyte. An associated kit, device, and method are provided.

Abstract: A marker for determining sensitivity of a patient to an anti-cancer agent, and novel cancer therapeutic means employing the marker, wherein the marker for determining sensitivity to an anti-cancer agent is a protein or a fragment, where in the protein or a fragment thereof exhibits a peak at m/z of 5,300 to 5,400, a peak at m/z of 6,130 to 6,230, a peak at m/z of 7,000 to 7,080 a peak at m/z of 7,840 to 7,920, a peak at m/z of 8,920 to 9,000, a peak at m/z of 12,440 to 12,560, a peak at m/z of 17,100 to 17,270, a peak at m/z of 18,290 to 18,470, a peak at m/z of 24,660 to 24,750, a peak at m/z of 35,980 to 36,290, a peak at m/z of 8,650 to 8,750, a peak at m/z of 9,100 to 9,200, a peak at m/z of 11,760 to 11,890, the peaks being determined by means of a mass spectrometer.

Abstract: The present invention refers to a fusion protein biosensor, comprising a peptide or protein domain that binds an analyte of interest (A), an entity that can produce a detectable signal (B), and an entity that binds to B and modulate the signal produced by B when A is not bound to the analyte. A method and a kit for detecting a presence or amount of an analyte molecule using the fusion protein is also disclosed.

Abstract: A biosensor for use in detecting the presence of diseases, the biosensor comprising a detector for detecting a presence of at least one marker indicative of a specific disease. A method of determining efficacy of a pharmaceutical for treating a disease or staging disease by administering a pharmaceutical to a sample containing markers for a disease, detecting the amount of at least one marker of the disease in the sample, and analyzing the amount of the marker in the sample, whereby the amount of marker correlates to pharmaceutical efficacy or disease stage. Markers for gynecological disease selected from the list in Table 6. An immuno-imaging agent comprising labeled antibodies, whereby the labeled antibodies are isolated and reactive to proteins overexpressed in vivo. Informatics software for analyzing the arrays of claim 4, the software including analyzing means for analyzing the arrays.

Abstract: Methods are provided that detect cognitive impairment including mild cognitive impairment and Alzheimer disease by using a protein or its partial peptide that differs in presence or absence. Novel biomarkers are also provided for cognitive impairment and non-psychiatric disease, as well as methods for detecting cognitive impairment using such biomarkers. Specifically, a biomarker for diagnosis is provided that comprises a protein fragment or peptide of not less than 5 amino acid residues arising from at least one protein or peptide selected from the group of proteins consisting of an amino acid sequence expressed by SEQ ID NO: 1, 3, 6, 8, 10, 13, 15, 18, or 20 and selected from the group of partial peptide in these proteins consisting of an amino acid sequence expressed by SEQ ID NO: 2, 4, 5, 7, 9, 11, 12, 14, 16, 17, 19, or 21.

Abstract: A microfluidic cartridge including on-board dry reagents and microfluidic circuitry for determining a clinical analyte or analytes from a few microliters of liquid sample; with docking interface for use in a host workstation, the workstation including a pneumatic fluid controller and spectrophotometer for monitoring analytical reactions in the cartridge.

Abstract: Compounds include carbamate derivatives of vitamin D including vitamin D3 and vitamin D2. The compounds are useful in methods and kits for determining the presence and/or amount of vitamin D including vitamin D analogs and metabolites thereof in a sample suspected of containing the same.

Abstract: The present invention relates to a method of diagnosis and therapy of cancers expressing the HER2 receptor. The invention provides antibodies or fragments thereof that recognise an epitope of the HER2 receptor truncated form CTF-611, said epitope being defined by a sequence included in SEQ ID NO: 2, and that are capable of discriminating between CTF-611 and CTF-616 (represented by SEQ ID NO:7), preferably additionally capable of discriminating between CTF-611 and CTF-613 (represented by SEQ ID NO:6). The invention also provides a method of cancer diagnosis using the disclosed antibodies, which comprises the detection of the presence of the HER2 receptor truncated form consisting of the amino acid sequence SEQ ID NO: 1 in a patient sample.

Abstract: A composition includes a first probe capable of binding to a first analyte and a first initiator bonded to the first probe. The composition further includes a second probe capable of binding to a second analyte and a second initiator bonded to the second probe. At least one of the first initiator or the second initiator is capable of initiating a controlled polymerization reaction. An associated kit, device, and method are provided.

Abstract: The invention describes biomarkers which can be used to predict the likelihood that an individual will develop Diabetes. The biomarkers can also be used to screen large groups in order to identify individuals at risk of developing Diabetes.

Abstract: The invention describes antibodies that bind venlafaxine and O-desmethylvenlafaxine. The antibodies are derived from novel haptens and immunogens and are used in methods and kits to detect and quantify venlafaxine and O-desmethylvenlafaxine. The invention also describes novel detecting agents which can be used in the methods and kits of the invention.

Abstract: The invention relates to in vitro method for quantitating the antibodies specific for High mobility group box I (HMGB1) contained in a sample, in particular a serum sample or a cerebrospinal fluid sample obtained from a patient, and the use of this method in the prognostic and/or diagnosis of neurological disorders. These methods are in particular applicable to the monitoring of the human immunodeficiency virus (HIV) infection of a subject who is known to be infected with HIV and in the prognostic and/or diagnostic of the state of progression of Acquired immune deficiency syndrome (AIDS) or the state of progression toward AIDS, in particular the state of progression or the state of progression toward neurological disorders associated with AIDS. Finally, the invention is also about method to determine the immune deficiency or level of immune activation of a patient, in particular a HIV-infected patient.

Abstract: The disclosure relates, in some embodiments, to sequences of a novel mutant or variant of the hepatitis B surface antigen (HBsAg) and methods for detecting this genome and protein variant, and antibodies directed against it, from patients' samples.

Abstract: The present invention pertains to the field of tools for ensuring manufacture of polypeptides and quality control. Specifically, it relates to a method for determining of the amount of processed (active) Neurotoxin polypeptide in a solution comprising processed Neurotoxin polypeptide and partially processed or unprocessed Neurotoxin polypeptide. The present invention relates further to a device for determining the amount and a kit adapted to carry out the method of the present invention.

Abstract: The present invention relates to a use of a protein nanoparticle-based hydrogel, and more particularly, to a use of a protein nanoparticle-based hydrogel capable of highly sensitive and simultaneous multi-detection of disease markers by using a hydrogel to which a protein nanoparticle representing a disease marker detection probe is immobilized.